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NCT05248906 Clinical Trial

Giant Cell Arteritis - Optimization of Diagnostics

Giant Cell Arteritis Clinical Trial

— GAME  

Official title:
A Head-to-head Comparison of Ultrasound Versus Temporal Artery Biopsy in the Diagnosis of Giant Cell Arteritis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05248906
Other study ID # H-20032069
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 19, 2021
Est. completion date January 1, 2023

Study information
Verified date February 2022
Source Rigshospitalet, Denmark
Contact Michael Stormly Hansen
Phone 38 63 38 63
Email michael.stormly.hansen@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Giant cell arteritis - Optimization of diagnostics

Description:

A prospective study. Investigating the use of ultrasound, temporal artery biopsy, biomarkers and 18F-fluorodeoxyglucose positron emission tomography-computed tomography for establishing a diagnosis of giant cell (temporal) arteritis.

Recruitment information / eligibility
Status Recruiting
Enrollment 185
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Clinical suspicion of giant cell arteritis Meets the American College of Rheumatology Criteria: Age at disease onset => 50 years New headache Temporal artery abnormality Elevated erythrocyte sedimentation rate >=50 mm/hour Abnomal artery biopsy Exclusion Criteria: Active cancer Use of steroid for more than a week (the prior 6 months)

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Giant cell arteritis
Ultrasound 18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography Temporal artery biopsy

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Giant cell arteritis Clinical verification of giant cell arteritis diagnosis as evaluated with a combination of ultrasound, biopsy and PET/CT. Week 26
See also
  Status Clinical Trial Phase
Completed NCT03812302 - Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA) Phase 2
Recruiting NCT02257866 - Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Recruiting NCT04888221 - Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement Phase 3
Recruiting NCT05380453 - Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission Phase 3
Recruiting NCT02333708 - Study of Circulating Microparticles in Giant Cell Arteritis
Completed NCT01450137 - Tocilizumab for Patients With Giant Cell Arteritis Phase 2
Completed NCT03827018 - KPL-301 for Subjects With Giant Cell Arteritis Phase 2
Active, not recruiting NCT04519580 - Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Recruiting NCT04239196 - Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA Phase 2
Recruiting NCT06460142 - Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
Completed NCT03202368 - An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA) Phase 3
Not yet recruiting NCT02523625 - Giant Cell Arteritis: Improving Use of Ultrasound Evaluation N/A
Completed NCT03285945 - FDG Uptake in Large-Vessel Giant Cell Arteritis After Short-term, High-Dose Steroid Treatment N/A
Completed NCT02190916 - Vasculitis Illness Perception (VIP) Study N/A
Recruiting NCT01241305 - One-Time DNA Study for Vasculitis
Terminated NCT02531633 - Efficacy and Safety Study of Sirukumab in Patients With Giant Cell Arteritis Phase 3
Completed NCT03765424 - Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis
Completed NCT03409913 - Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA N/A
Completed NCT01910038 - Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study. Phase 2
Not yet recruiting NCT04012905 - Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering Phase 3